Subcutaneously implanted cannula and method for arterial access

ABSTRACT

A catheter with valve for implantation in a vascular structure of a living being. The catheter is in the general shape of a &#34;T&#34; with the top of the &#34;T&#34; implanted within the lumen of a vascular structure, and the leg of the &#34;T&#34; extending out of the vascular structure through an incision in the vascular structure. The lumen of the implanted portion of the catheter completely occupies the lumen of the vascular structure, causing all blood flow through the vascular structure to be directed through the implanted portion of the catheter. A valve is placed in the wall of the implanted portion of the catheter which opens into the lumen of the leg of the &#34;T&#34; of the catheter upon application of sufficient differential pressure between the lumens of the two portions of the catheter. The leg of the &#34;T&#34; is connected to the side wall of the implant portion of the catheter at an angle, such that the axis of the lumen of the leg of the &#34;T&#34; intersects the axis of the lumen of the implanted portion of the catheter at approximately a 45 degree angle.

The present application is a continuation-in-part of application Ser.No. 08/539,105, filed on Oct. 4, 1995, now U.S. Pat. No. 5,807,356 whichwas a continuation-in-part of application Ser. No. 08/183,151, filed onJan. 18, 1994, now U.S. Pat. No. 5,562,617 the full disclosures of whichare incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. The Field of Invention

The present invention relates to subcutaneously implanted cannulas usedto access the body's circulation. More particularly, this inventionprovides a cannula and method for establishing intermittent vascularaccess using an implanted cannula in the general shape of a "T".

The advent of hemodialysis for the treatment of end-stage renal diseasehas prompted the development of many vascular access devices for thepurpose of acquiring and returning large quantities of blood for passagethrough an extracorporeal circuit during hemodialysis procedure.Available devices have generally relied on the use of either indwellingvenous catheters or flow through shunt devices which create anartificial fistula between an artery and vein.

Venous catheters are limited by relatively poor draw flows and by theirtendency to be irritative resulting in vessel stenosis, thrombosis, andoccasionally vessel perforation. They frequently fail because ofinfection, weakness in the vessel wall, poor catheter position, and/orthrombus formation in the catheter lumen. Shunt devices which create afistulous blood flow between an artery and a vein have been the mainstayof modern vascular access for dialysis but are similarly problematic.Installation of these "shunts" is an extensive surgical procedureresulting in significant tissue trauma and pain. Once in place, theshunts result in additional cardiac output needs with as much asone-fifth of the cardiac output (approximately 1000 ml per minute)required for adequate function. In addition, the transfer of thearterial pressure wave results in damage to the vein at the point ofanastomosis with the shunt and can result in intimal hyperplasia andsubsequent thrombosis and shunt occlusion. When such occlusion occurs,another vein segment must be used for shunt revision, and exhaustion ofavailable sites is distressingly common and can be fatal. Repeatedpunctures of the wall of the shunt often result in eventual failure andrequire additional surgery to repair or replace the shunt. The expensein terms of both health care dollars and human misery is enormous.

Each of the available access technologies mentioned thus far are alsocomplicated by the possibility of recirculation of blood already passedthrough the extra-corporeal circuit resulting in the loss of treatmentefficiency. The harm done to patients by the "recirculation syndrome" isinsidious and at times undetected until great harm has been done.

Indwelling catheters which occupy only a portion of the vessel lumen aresubject to movement within the vessel, which can cause irritation oreven vessel perforation. Further, catheters which occupy only a portionof the vessel lumen, and which are inserted or threaded through thelumen for substantial distances tend to disrupt the normal flow of bloodthrough the vascular structure, altering the hemodynamics of the bloodflow in a manner which can damage the vessel, the components of theblood, and which can encourage thrombosis. Such catheters are generallyunsuitable for long term implantation in arteries.

What is needed is a cannula that can be implanted within an artery andthat will cause minimal disruption of blood flow through the lumen ofthe artery during use and nonuse of the cannula, which does not causevessel stenosis, thrombosis, or vessel perforation, which is capable ofhandling large quantities of blood, and which will retain its usefulnessfor a long period of time after implantation.

2. Description of the Background Art

Vascular access employing indwelling catheters is described in a numberof patents and publications including U.S. Pat. Nos. 3,888,249;4,543,088; 4,634,422; 4,673,394; 4,685,905; 4,692,146; 4,695,273;4,704,103; 4,705,501; 4,772,270; 4,846,806; 5,053,613; 5,057,084;5,100,392; 5,167,638; 5,108,365; 5,226,879; 5,263,930; 5,281,199;5,306,255; 5,318,545; 5,324,518; 5,336,194; 5,350,360; 5,360,407;5,399,168; 5,417,656; 5,476;451; 5,503,630; 5,520,643; 5,527,277; and5,527,278; and EP 228 532; and Wigness et al. (1982) paper entitled"Biodirectional Implantable Vascular Access Modality" presented at theMeeting of the American Society for Artificial Internal Organs, Apr.14-16, 1982, Chicago, Ill.

Catheters having distal valves are described in a number of patentsincluding U.S. Pat. Nos. 274,447; 3,331,371; 3,888,249; 4,549,879;4,657,536; 4,671,796; 4,701,166; 4,705,501; 4,759,752; 4,846,806;4,973,319; 5,030,710; 5,112,301; 5,156,600; and 5,224,978.

Implantable dialysis connection parts are described in a number ofpatents including U.S. Pat. Nos. 4,692,146; 4,892,518; 5,041,098;5,180,365; and 5,350,360.

SUMMARY OF THE INVENTION

The present invention provides improved implantable vascular cannulaswhich are particularly useful for providing long-term access to thearterial vasculature, including both native arteries and artificialarterial lumens (such as an arteriovenous (AV) shunt or an arterialgraft. The cannulas of the present invention comprise a tubular bodywhich is implantable within an arterial lumen and an access leg havingone end attached to a side wall of the tubular body. Both the tubularbody and the access leg have lumens therethrough, with the lumen of thetubular body being configured to receive the entire blood flow of thearterial lumen in which it is implanted. The access leg, which isattached to the tubular body in a generally T-shaped configuration, thusprovides for access into the lumen of the tubular body for eitherwithdrawing blood (e.g. for hemodialysis or other extra-corporealtreatment) or for introducing drugs or other media into the arterialblood flow.

The arterial access cannula may be implanted either subcutaneously ortranscutaneously. By transcutaneous, it is meant that a portion of theaccess leg will pass outwardly through the patient's skin to permitdirect arterial access using external drug pumps, syringes, or otherequipment. It will be appreciated, of course, that a hemostasis valvemust be provided on the access leg to prevent uncontrolled blood loss.Usually, any transcutaneous use of the cannula of the present inventionwill be only for a short time.

More usually, the cannula of the present invention will be intended forsubcutaneous use. In that case, an access port is connected to the openend of the access leg and is also subcutaneously implanted beneath thepatient's skin. The access port will be suitable for attachment toneedles, tubes, catheters, and other devices which may be percutaneouslyintroduced into the access port to provide a desired externalconnection. An example of an access port comprises a chamber having apenetrable membrane on one side thereof. Temporary access to the chamberis formed by penetrating the needle, tube, or catheter through thepenetrable membrane.

In all cases, the T-configured arterial cannula of the present inventionis an improvement over prior indwelling catheters in a number ofrespects. The tubular body is firmly anchored within the artery and notsubject to being moved or dislodged by blood flow. Thus, trauma to thearterial wall from movement of the cannula is significantly lessened.Moreover, by assuring that the lumen of the tubular body has across-sectional shape and dimensions which closely match those of thearterial lumen, smooth blood flow through the cannula can be enhancedwhile the risk of thrombus formation is substantially reduced.

In a preferred construction, the arterial cannula will include anisolation valve, at or near the junction between the access leg and thetubular body. The isolation valve can be any type of valve that closesor inhibits flow between the tubular body lumen and the access leg lumenin the absence of a pressure drop therebetween. Thus, when blood is notbeing withdrawn and/or when drugs or other media are not beingintroduced, the isolation valve will close and isolate the lumen of theaccess leg from arterial blood flow. Such isolation is a significantadvantage since it reduces the risk of thrombus formation within theaccess leg and thrombus release into the arterial lumen. Often, it willbe desirable to flush the lumen of the access leg with an anti-coagulantfluid after each use. The removal of static blood and the placement ofthe anti-coagulant fluid further decreases the risk of thrombusformation and release. The isolation valve may be in a variety of forms,including slit valves, flap valves, ball valves, and may further beconfigured to provide for one-way or bi-direction flow. For example, inthe case of arterial cannulas used for withdrawing blood, it will oftenbe advantageous to have a one-way isolation valve which permits bloodflow from the tubular body into the access leg, but inhibits reverseflow of any materials from the access leg into the lumen. In the case ofdrug and other infusions into the artery, it may be desirable to providea one-way isolation valve which permits such introduction, but preventsreflux of blood into the access leg. A particularly preferred valve is aslit valve formed into the wall of the tubular body, as illustrated indetail hereinafter. When such a slit valve is closed, the inner profileof the tubular body lumen will be substantially smooth and free fromdiscontinuities caused by the valve.

The arterial cannula may be formed from any one or a combination of avariety of biocompatible materials. By biocompatible, it is meant thatthe material(s) will be suitable for a long term implantation withinpatient vasculature and tissue and will be free from immunogenicity andinflammatory response. Usually, the cannula will be formed in whole orin part from an organic polymer, such as silicone rubber, polyethylenes,polyurethanes, polyvinylchloride, polytetrafluoroethylene (PTFE),polysulfone, or the like. Portions of the cannula may be reinforced, forexample the access leg may include circumferential reinforcement toenhance its hoop strength without significantly diminishing flexibility.Such reinforcement may take the form of a helical wire or ribbon,axially spaced-apart hoops, or the like. Preferably, the reinforcementmay be achieved by molding the access leg to incorporate circumferentialcorrugation, i.e. a plurality of axially spaced-apart circumferentialribs along all or a portion of its lengths. In all cases, it isdesirable that the internal lumen of the access leg and the tubular bodyremain as smooth as possible to avoid disturbances to blood flow.

The tubular body of the arterial cannula will have dimensions compatiblewith implantation within a variety of arteries, including both native(natural) arteries and implanted synthetic arteries. The most commonnative arteries in which the cannulas may be implanted include theproximal ulnar, proximal radial, brachial artery, axillary artery, andsubclavian artery. Implanted synthetic arteries include bypasses, shunts(e.g. AV shunts), arterial grafts, and the like. Both native arteriesand implanted synthetic arteries have lumens, and reference to "arteriallumens" herein is intended to refer to both such lumens.

Generally, the length of the tubular body will be in the range from 10mm to 50 mm and the outer diameter will be in the range from 3 mm to 10mm. The diameter of the lumen of the tubular body will generally be inthe range from 1 mm to 8 mm. The access leg will usually have a lengthin the range from 25 mm to 700 mm and an outer diameter in the rangefrom 3 mm to 10 mm. The lumen diameter of the access leg will generallybe in the range from 2 mm to 8 mm.

In a preferred aspect of the present invention, at least a portion ofthe access leg of the arterial cannula will be sufficiently compliant sothat substantially no forces are transmitted from the access leg backinto the tubular body. For proper functioning of the arterial cannula,it is important that the tubular body remain properly aligned within thearterial lumen. This can be achieved by fabricating at least a portionof the access leg adjacent to the tubular body to have a low bendingstiffness. The hoop strength of the access tube, in contrast, shouldremain relatively high, being at least sufficient to maintain patency ofits lumen at internal pressures below -250 mmHg, preferably below -400mmHg. Use of the helical reinforcement designs described above helpsassure that the access leg can be sufficiently flexible while retainingsufficient strength.

In a first specific aspect of the present invention, a system forperforming extracorporeal blood treatment comprises an arterial cannulaas described above in combination with a venous cannula which isimplantable within a venous lumen. The venous cannula will also comprisean access leg, but will usually be in the form of a conventionalin-dwelling catheter or a distal portion of the cannula as within thevenous lumen in a generally free or unrestricted manner. The use ofconventional in-dwelling cannula in the venous vasculature is notproblematic. Usually, both the arterial cannula and the venous cannulaof the systems of the present invention will further include accessports intended to be connected to catheters for completing anextracorporeal circuit. Such access ports may be of generallyconventional construction and may be connected to extracorporealtreatment circuits in a general conventional manner.

In another aspect, the present invention comprises a method forimplanting an arterial access cannula within the lumen of an artery. Themethod comprises surgically exposing the artery and making an incisionin its wall. The tubular body of the access channel is introducedthrough the incision and into the lumen of the artery. The lumen of thetubular body will be evenly circumferentially aligned with the arteriallumen, and the incision then closed. In some instances, the tubular bodywill have flared portions at either end, and the flared portions canoptionally be tied within the artery to further anchor the cannulatherein. The method may further comprise an initial step of determininga cross-sectional dimension of the artery and selecting a tubular bodyhaving a cross-section dimension substantially equal to that of thearterial lumen. The method may still further comprise subcutaneouslyintroducing an arterial port, where the arterial port is connected orconnectable to the access leg of the arterial access cannula. Thearterial port may be introduced through the same incision as thearterial cannula. Alternatively, the arterial port may be introducedthrough a second incision formed remotely from the first incision, andthe port thereafter connected to the access leg by forming asubcutaneous path between the two.

The method may still further comprise introducing a venous cannula bysurgically exposing a vein, and introducing the venous cannulatherethrough. The venous port may then be introduced, either through thesame or a different surgical incision, in order to form a desiredsubcutaneous access assembly. By having introduced both an arterialcannula and a venous cannula, the patient is ready for access tohemodialysis or a variety of other extracorporeal treatment modalities.

In still further aspects of the present invention, methods are providedfor performing extracorporeal blood treatment by percutaneouslyattaching a first catheter to an access leg of a subcutaneouslyimplanted arterial cannula having a tubular body disposed within anarterial lumen. A second catheter is then percutaneously attached to asubcutaneously implanted venous access catheter, and blood may becirculated from the first catheter through an extracorporeal circuit tothe second catheter. The first and/or second catheters are typicallypercutaneously penetrated to connect to the access leg, e.g. bypenetrating a needle or needle-introduced catheter through a membrane ofa conventional access port. The extracorporeal circuit may behemodialysis, and the method may further comprise stopping bloodcirculation and filling at least the access leg of the arterial cannulawith an anti-coagulant fluid.

In still a further aspect of the present invention, a method foradministering a fluid medium into an artery comprises percutaneouslyattaching a needle or needle-introduced catheter to an access leg of asubcutaneously implanted arterial cannula having a tubular bodyimplanted within the arterial lumen. The fluid medium is then infusedthrough the needle or catheter into the access leg and from there intothe lumen of the tubular body. The fluid medium will usually be amedication, but could also be a diagnostic or other conventional agentintroduced to arterial blood flow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of the preferred embodiment of thepresent invention implanted within a vascular structure.

FIG. 2 shows a cross-sectional view of the preferred embodiment of thepresent invention.

FIG. 3 shows a cross-sectional view of the valve of the preferredembodiment of the present invention in the closed position.

FIG. 4 shows a cross-sectional view of the valve of the preferredembodiment of the present invention in the open position.

FIGS. 5 and 6 are top and side elevational views, respectively, of apercutaneous access port which may be utilized with either the arterialcannula or venous cannula of the present invention.

FIG. 7 is a cross-sectional view taken along line 7--7 of FIG. 5.

FIG. 8 is a cross-sectional view taken along line 8--8 of FIG. 5.

FIG. 9 is an isometric view of a second embodiment of an arterialcannula constructed in accordance with the principles of the presentinvention.

FIG. 10 is a detailed view of the tubular body of the cannula of FIG. 9shown in partial cross-section.

FIG. 11 illustrates subcutaneous implantation of the arterial cannula ofFIG. 9 in tissue.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1 there is depicted an arterial cannula 10 constructedin accordance with the principles of the present invention implantedwithin an arterial lumen 20. The cannula is shaped generally like a "T"and is comprised of two primary sections; the tubular body 25 and theaccess leg 30. The intravascular tube 25 is an elongated tube having asingle lumen 26, open on both ends. When implanted within the lumen 20,the tubular body 25 will have an upstream end 27, and a downstream end28, determined by the direction of blood flow in the vascular structure20. In FIG. 1 the direction of blood flow is indicated by the arrow 21.The cannula however, can be implanted in either orientation.

The access leg 30 is an elongated tube having a single lumen 31. Adistal end 32 of the access leg 30 is connected to the tubular body 25,generally near the mid-point thereof. The access leg 30 may extend fromthe tubular body 25 at any angle, including a 90 degree angle, but it ispreferred that the access leg 30 of the cannula 10 extend from thetubular body 25 in a direction which is inclined toward the upstream end27 of the tubular body 25. The angle formed between the access leg 30and the upstream end 27 of the tubular body 25 is an acute angle. Theangle formed between the access leg 30 and the downstream end 28 of theintravascular tube 25 is an obtuse angle. A preferred angle between theaccess leg 30 and the upstream end 27 of the tubular body 25 is between30° and 60°, usually being approximately 45 degrees.

A valve 40 is preferably located at the point of connection between thedistal end 32 of the access leg 30 and the tubular body 25. Thepreferred valve 40 is a slit valve. Such valves are well known in theart. As best shown in FIG. 3, the slit valve is comprised of a membrane41 which has a slit 42 extending partially across the membrane 41 andcompletely through the membrane 41. The membrane 41 acts to preventfluid flow through the lumen 31 of the access leg 30, except whenadequate differential pressure exists on opposite sides of the membrane41 to cause the slit 42 to open, as is shown in FIG. 4. The membrane 41is located such that the side of the membrane 41 located towards thevascular structure is essentially flush with the inner wall of theintravascular tube 25. When the catheter 10 is not in use, the membrane41 of the valve 40 and the inner surface of the tubular body 25 form acontinuous tube that has minimal impact on normal blood flow through thearterial lumen.

In the preferred embodiment, the membrane 41 is comprised of a portionof the side wall of the tubular body 25. To create the valve 40, a slit42 is cut in the side wall of the tubular body 25 to correspond to thepoint of connection of the access leg 30. In this manner, when the valveis closed, the inner surface of the tubular body 25 is a continuoussmooth surface which has minimal impact on normal blood flow. When thevalve 40 opens, fluid flow between the lumen 31 and the access leg 30and the lumen 26 of the intravascular tube 25 occurs.

The outer circumference of the tubular body 25 is provided with expandedbarbs 29 to hold cannula 10 in place within the vascular structure 20.One each of these expanded barbs 29 may be placed proximate the upstreamend 27 and proximate the downstream end 28 of the tubular body 25. Theexpanded barbs 29 have an enlarged outer circumference which tends toslightly distend the wall of the arterial lumen 20, providing a snugfit, but not preventing the continued viability of the arterial wall.Additional areas of expanded outer diameter (not shown) may be spacedalong the outer surface of the tubular body 25. The fit between thearterial wall and the tubular body 25 must be of sufficient tightness toprevent passage of blood between the arterial wall and the outer surfaceof the tubular body 25. Optionally, it may be possible to place ties orclamps (not shown) about the outer wall of the artery adjacent to theexpanded barbs 29 to hold the cannula 10 in place. All blood flowingthrough the arterial lumen should pass through the lumen 26 of thetubular member 25.

In use, the proximal end 33 of the access leg 30 of the cannula 10 maybe connected to a subcutaneous port, or may extend transcutaneously(i.e. through the skin). The cannula 10 is suitable for use with anydevice requiring or facilitating intermittent vascular access. Thecannula 10 of the present invention is particularly useful for arterialaccess in hemodialysis, since such treatment requires large quantityblood flow, and requires relatively frequent vascular access over a longperiod of time. For such use two cannulas 10 may be surgicallyimplanted. One of the devices is implanted in an artery. The otherdevice is implanted in a vein. Usually, however, a conventionalin-dwelling catheter will be used for the venous access since veinaccess is easer to establish. In this manner both the venous andarterial circulations are accessed separately, without fistulouscommunication. Current use of shunts, which create a fistulousconnection between artery and vein, not only involve a more extensivesurgical procedure, but are fraught with problems including increasedcardiac output requirements, damage to the vein due to arterial pressurewaves, and frequent shunt occlusion or thrombosis.

During hemodialysis, blood is removed from the arterial cannula 10implanted in an artery and is subjected to the extracorporeal dialysiscircuit. Removal occurs by reducing the pressure in the access leg 30 ofthe cannula 10, until the slit valve 40 opens, and blood flows from thetubular body 25 into the access leg 30. The treated blood is returned toa cannula implanted in a vein. At the completion of the dialysistreatment of the access leg 30 of cannula 10 is filled withanti-coagulant fluid, to discourage thrombosis and occlusion of theaccess legs 30. A similar process may be used for apheresis or exchangetransfusion procedures. Additionally, a single arterial cannula 10 maybe used for frequent administration of medication into artery or vein,or for large volume fluid infusions.

Surgical implantation of the arterial cannula 10 is a straight forwardprocedure. The chosen artery is located and isolated, and a smallincision is made in the lumenal wall. The tubular body 25 of the cannula10 is inserted into the incision, with the access leg 30 extending outof the lumen through the incision. The incision is then sutured toprovide a snug fit around the access leg 30. The proximal end 33 ofaccess leg 30 of the cannula 10 is then attached to a subcutaneous port(described hereinafter) or other device requiring intermittent vascularaccess.

Materials of construction well known in the art may be used for themanufacture of the cannula 10. However, it is important that the tubularbody 25 be particularly biocompatible with the arterial wall 20, sinceit is intended that the wall in contact with the cannula 10 remainviable. Since the cannula 10, unlike most prior art catheters, is notdesigned to be pushed or threaded some distance into a blood vessel, theaccess tube of the cannula may be comprised of relatively flexiblematerial. This may be accomplished by including a spring or otherreinforcement element (not shown) within the walls of the cannula 10 tomaintain hoop strength. The materials of construction of the tubularbody should be of sufficient rigidity to maintain the preferred anglebetween the access leg 30 and the tubular body. The dimensions of thecatheter 10 depend upon the size of the vascular structure 20 to beaccessed. Typically the outer diameter of the tubular body 25 will bebetween 3 and 10 mm, with a wall thickness of approximately 0.5 to 1 mm,yielding a lumen 26 diameter of between 1 and 8 mm. A typical length ofthe tubular body 25 from upstream end 27 to downstream end 28 is between10 and 50 mm. The maximum diameter of the outer surface of the expandedbarbs 29 is approximately 30 percent greater than the diameter of thetubular body 25 where no expanded barb 29 is present. The length andflexibility of the access leg can vary depending upon the use of thecatheter 10. For use with subcutaneous ports an access leg 30 length ofapproximately 25 mm to 700 mm, usually about 100 mm is generallysufficient.

Referring now to FIGS. 5-8, an exemplary implantable port 100 will bedescribed. The implantable port 100 may be used with either the arterialcannula 10 described above, or with more conventional in-dwelling,cannula which may be used in systems for venous access, as described inmore detail hereinafter. The port 100 includes a single hematologicchamber 125, where the base and sides are formed by a circumferentialwall 126. The port 100 further includes wall 126 and a cover 120 whichholds a replaceable diaphragm 127 in place. The cover 120 is removableto allow replacement of the diaphragm 127 if needed. A base 129 of theport 100 comprises a flange having apertures 130 which permit fasteningof the port to underlying tissue, typically using sutures. A connector128 open to one end of the chamber 125 is connectable to the free end ofaccess leg 30 which forms part of the arterial cannula 10 describedabove.

Referring now to FIGS. 9 and 10, an alternative embodiment of anarterial cannula 200 constructed in accordance with the principles ofthe present invention will be described. The cannula 200 includes both atubular body 202 and an access leg 204. The access leg 204 comprises aportion adjacent to the tubular body 202 including a plurality ofcircumferential ribs or corrugations 206 which provides substantial hoopstrength to the leg without diminishing the desired flexibility. Theremainder of the access leg 204 comprises larger sections 208, with thedistal end 210 being suitable for attachment to the vascular port 100 atconnector 128, as described previously.

The tubular body 202 comprises a molded insert 230 including a main bodyportion 232 and a branch portion 234. An isolation valve 236 is formedat the end of branch 234, generally as described above with previousembodiments. Tubular body 202 is connected to the adjacent end of theaccess leg 206 by over molding an exterior body 238. Usually, a titaniumtube 240 is placed within the junction between the end of access leg 206and the end of branch portion 234. The tube may be titanium or otherbiocompatible metal. The insert 230 is typically formed from arelatively soft material, such as 40D to 50D silicone rubber. The outerportion 238 of the tubular body 202 is formed from a similar material,such as 50D silicone rubber. The access tube may be also formed fromsilicone having a hardness of 40D to 50D. Conventional moldingtechniques may be used to form all these parts.

Referring now to FIG. 11, the tubular body 202 of the arterial cannula200 may be implanted within an artery A by first surgically exposing theartery and thereafter forming an incision in the side of the artery. Thetubular body 202 is the introduced through the incision, and theincision sutured to hold the body within the arterial lumen. The accessleg 204 is then moved to a location where the arterial port 100 is to beimplanted. Note that the entire assembly of the arterial cannula 200 andarterial port 100 may be implanted together within a single incision.Alternatively, the arterial cannula 200 and the arterial port 100 may beseparately implanted, with the access leg 204 being separatelypositioned therebetween.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that certain changes and modificationsmay be practiced within the scope of the appended claims.

What is claimed is:
 1. A method for performing extracorporeal bloodtreatment, said method comprising:percutaneously attaching a firstcatheter to a subcutaneous implanted access leg of a subcutaneouslyimplanted arterial cannula having a tubular body disposed within anarterial lumen, wherein said tubular body has a lumen which passesarterial blood flow therethrough and said access leg is attached to aside of the tubular body; percutaneously attaching a second catheter toa subcutaneously implanted venous access cannula; and circulating bloodfrom the first catheter through an extracorporeal circuit to the secondcatheter.
 2. A method as in claim 1, wherein the arterial lumen ispresent in an artery selected from the group consisting of the proximalulnar, proximal radial, brachial artery, axillary artery, subclavianartery and synthetic arteries.
 3. A method as in claim 1, wherein thelumen of the tubular body is selected to have a cross-sectionaldimension substantially equal to that of the arterial lumen.
 4. A methodas in claim 1, wherein the tubular body has an outer diameter in therange from 10 mm to 50 mm and a length in the range from 3 mm to 10 mm.5. A method as in claim 1, wherein at least the first catheter isaccessed by penetrating a needle or a needle-introduced catheter toattach to the access leg.
 6. A method as in claim 5, wherein attachingthe first catheter comprises penetrating a needle through a penetrablemembrane on a port attached to the access leg.
 7. A method as in claim1, wherein the extracorporeal circuit is a hemodialysis circuit or anapheresis circuit.
 8. A method as in claim 1, further comprisingstopping circulation and filing at least the arterial cannula with ananticoagulant fluid.
 9. A method as in claim 8, wherein theanti-coagulant fluid is maintained within the cannula by a valvedisposed near the distal end of the access leg.
 10. A method foradministering fluid medium into an artery, said methodcomprising:percutaneously attaching a needle or needle-introducedcatheter to a subcutaneously implanted access leg of a subcutaneouslyimplanted arterial cannula having a tubular body implanted within anarterial lumen, wherein said tubular body has a lumen which passesarterial blood flow therethrough and said access leg is attached to aside of the tubular body; infusing a fluid medium through the needle orneedle-introduced catheter into the access leg and to the blood passingthrough the lumen of the tubular body.
 11. A method as in claim 10,wherein the artery is selected from the group consisting of the proximalulnar, proximal radial, brachial artery, axillary artery, subclavianartery and synthetic arteries.
 12. A method as in claim 10, wherein thelumen of the tubular body is selected to have a cross-sectionaldimension substantially equal to that of the blood vessel.
 13. A methodas in claim 10, wherein the tubular body has an outer diameter in therange from 10 mm to 50 mm and a length in the range from 3 mm to 10 mm.14. A method as in claim 10, wherein infusing the fluid medium comprisespassing the fluid medium through a valve disposed at the end of theaccess leg adjacent to the tubular body.
 15. A method as in claim 14,wherein the valve is a slit valve extending across the cannula near itsdistal end.
 16. A method as in claim 14, further comprising filling theaccess leg of the cannula with an anti-coagulant fluid when medicationis not being introduced therethrough.